31.05.2022, 10:30

AffaMed Therapeutics Announces First Patient Dosed in the US Phase 1 Clinical Trial of AM712 in Retinal Disease

SHANGHAI, May 31, 2022 /PRNewswire/ -- AffaMed Therapeutics ("AffaMed"), a global clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, announces that the first patient has been dosed in its US Phase 1 study of AM712 (ASKG712), a novel proprietary bispecific biologic molecule blocking both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) for the treatment of retinal diseases. The study will investigate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with neovascular age-related macular degeneration (nAMD).

Dr. Dayao Zhao, CEO of AffaMed commented: "Dosing the first patient with AM712 is another example of the AffaMed team's effective execution and global clinical development expertise. Initiating treatment in retinal disease patients marks an important milestone for AffaMed, and we look forward to advancing AM712 as an innovative and differentiated therapy for the patient population with nAMD and other retinal diseases."

Age-related macular degeneration (AMD) is an acquired degeneration of the retina that results in significant central vision loss due to neovascular (choroidal neovascular membrane formation) and non-neovascular (drusen and retinal pigment epithelium abnormalities) damages.  Neovascular AMD is an advanced form of macular degeneration that has historically been the leading cause of AMD-related vision loss. Simultaneous neutralization of VEGF and Ang-2 represents a novel therapeutic approach to treat nAMD with better efficacy.

In late 2021, AffaMed entered into a licensing agreement with AskGene Pharma Inc. ("AskGene") for the exclusive rights to develop, manufacture, and commercialize AM712 globally in ex-Asia plus Japan territories. Soon after, the Investigational New Drug (IND) application, filed by AffaMed for the clinical development of AM712 was cleared by the United States Food and Drug Administration (FDA) in January 2022.

About AffaMed Therapeutics

AffaMed Therapeutics is a clinical stage biopharmaceutical company focused on developing and commercializing transformative pharmaceutical, digital and surgical products that address critical unmet medical needs in ophthalmological, neurological and psychiatric disorders for patients in Greater China and around the world. The leadership team at AffaMed Therapeutics has gained deep industry expertise and an extensive track record in high-quality discovery, clinical development, regulatory affairs, business development, manufacturing, and commercial operations at leading multi-national biopharmaceutical companies in China and globally.

About AM712 (ASKG712)

AM712 is a novel bispecific biologic molecule specifically designed for ocular use. It provides dual inhibition of two important disease-relevant pathways in retinal diseases, VEGF and Ang-2. In pre-clinical studies, AM712 demonstrated robust efficacy, good ocular pharmacokinetics, and the desired safety profile supporting clinical exploration. AskGene received China CTA clearance for AM712 from NMPA in January 2022.

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Source: AffaMed Therapeutics